FDA 483 - Cambridge Isotope Laboratories, Inc. - August 30, 2022

Cambridge Isotope Laboratories, Inc. in Andover, MA, an Active Pharmaceutical Ingredient Manufacturer, was cited for a significant quality control issue. The firm failed to adequately investigate an out-of-specification result for Loss on Drying (LOD) during accelerated stability studies for Urea (C13, 99%). This failure involved not evaluating the potential impact on long-term stability data or the container closure system, instead prematurely concluding the bottle was unsuitable.